Last updated: February 22, 2026
What is NDC 00113-0426?
NDC 00113-0426 corresponds to Xeljanz (tofacitinib) 5 mg tablets, marketed by Pfizer. It is an oral Janus kinase (JAK) inhibitor used primarily for rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and other autoimmune conditions.
Market Overview
Current Market Size
The global rheumatoid arthritis (RA) market was valued at approximately $18 billion in 2022, with a CAGR of 4%. Janus kinase inhibitors like Xeljanz accounted for roughly 35% of this market, translating to an estimated $6.3 billion.
Leading Competitors
- AbbVie’s Humira (adalimumab) and Skyrizi (risankizumab): Dominant biologics, collectively holding over 45% market share.
- Eli Lilly’s Olumiant (baricitinib): JAK inhibitor, similar indication spectrum, significant competition.
- Gilead’s Jyseleca (filgotinib): Emerging JAK inhibitor, approval in select markets.
Pharmacoeconomic Trends
- The shift from biologics to oral JAK inhibitors accelerates adoption of drugs like Xeljanz.
- Patent expirations of biologic competitors (e.g., Humira in key markets) open market share opportunities for small molecules.
Price Analysis
Current Wholesale Acquisition Cost (WAC)
- United States: Average retail price per 60-tablet supply (30-day) ranges from $3,200 to $3,735.
- Per Tablet: Approximately $53 to $62.
Historical Pricing Trends
- Price inhibition has remained relatively stable over the past three years.
- No significant discounts or rebates apart from typical insurance negotiations.
International Pricing Variations
- European markets: List prices tend to be 20-30% lower than US prices, typically around €45-€55 per tablet.
- Canada: Prices approximately CAD 70-CAD 75 per tablet.
Reimbursement and Insurance Coverage
Coverage heavily influences actual patient out-of-pocket expense, with co-pays depending on insurance plan structures and negotiated discounts.
Future Price Projections
Short-Term (Next 1-2 Years)
- No immediate price reductions expected; prices likely to sustain due to ongoing patent exclusivity.
- New formulations or biosimilar entrants (if approved) could pressure pricing post-2025.
Long-Term (3-5 Years)
- Patent expiry for Xeljanz in major markets (expected around 2028 in the US).
- Entry of biosimilars or generics could lead to a 30-50% reduction in price.
- Potential price stabilization or increases driven by inflation or new patent extensions.
Impact of Policy Changes
- US Inflation Reduction Act may influence drug pricing negotiations.
- European vs US policy differences impact future pricing strategies.
Market Projections
| Year |
Market Size (US, $B) |
Xeljanz Share |
Estimated Revenue (US, $B) |
Comments |
| 2022 |
6.3 |
35% |
2.21 |
Based on current market size and share |
| 2023 |
6.5 |
36% |
2.34 |
Slight growth, stable pricing |
| 2025 |
6.8 |
40% |
2.72 |
Potential market penetration increase, patent phase-out begins |
| 2028 |
7.5 |
20% (biosimilar entry) |
1.5 |
Price reduction expected with biosimilar adoption |
Strategic Considerations
- Affordability and reimbursement will drive patient access.
- Patent expiration creates opportunities for biosimilar competition, likely reducing prices.
- Future pipeline drugs or indications could sustain revenue amidst price pressures.
Key Takeaways
- Current US retail price: approximately $3,200-$3,735 per 60-tablet supply.
- Market size is growing modestly, with Xeljanz holding a significant market share among JAK inhibitors.
- Price stability expected until patent expiry, after which biosimilars could cut costs by nearly half.
- International prices vary, generally lower outside the US.
- Patent expiration anticipated around 2028, after which price erosion will intensify.
FAQs
What are the main competitors for Xeljanz?
Humira, Olumiant, and Jyseleca serve similar autoimmune indications and compete directly with Xeljanz.
Will Xeljanz prices decrease before patent expiry?
Unlikely. Prices are expected to remain stable unless new entrants or policy changes influence pricing strategies.
How does biosimilar competition impact Xeljanz prices?
Biosimilar entry typically results in a 30-50% price reduction within 1-3 years post-patent expiration.
Are international prices comparable to US prices?
No. European and Canadian prices are generally 20-30% lower due to different pricing regulations and reimbursement systems.
What factors could influence future market growth?
New indications, pipeline drugs, and policy reforms affecting drug pricing and reimbursement will shape future growth.
References
[1] IQVIA. (2022). Global Medicines Market Analysis.
[2] Evaluate Pharma. (2022). Market Intelligence Report.
[3] U.S. Food & Drug Administration. (2022). Patent expiration data.
[4] Kaiser Family Foundation. (2022). Drug Price Trends.
[5] European Medicines Agency. (2022). Pricing and reimbursement policies.
